A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

NCT02288559 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GX29455
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 36

Brief Summary

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24

  GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.

  Baseline, Week 24

Secondary Outcomes (5)

• Serum Concentrations of Lampalizumab (Q2W)

  Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose

• Serum Concentrations of Lampalizumab (Q4W)

  Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination

• Percentage of Participants With Ocular Adverse Events (AEs)

  Baseline up to approximately 30 weeks

• Percentage of Participants With Systemic (Non-ocular) Adverse Events

  Baseline up to approximately 30 weeks

• Percentage of Participants With Anti-Lampalizumab Antibodies

  Baseline up to approximately 30 weeks

Study Arms (4)

Lampalizumab: Open-label Safety Run-In

EXPERIMENTAL

Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.

Drug: Lampalizumab

Q2W Lampalizumab: Randomized Treatment

EXPERIMENTAL

Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.

Drug: Lampalizumab

Q4W Lampalizumab: Randomized Treatment

EXPERIMENTAL

Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.

Drug: Lampalizumab

Sham: Randomized Treatment

SHAM COMPARATOR

Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.

Other: Sham

Interventions

Sham OTHER

Sham injection will be administered as a matching intravitreal injection of lampalizumab.

Sham: Randomized Treatment

Lampalizumab DRUG

10 mg dose of lampalizumab administered intravitreally

Lampalizumab: Open-label Safety Run-In; Q2W Lampalizumab: Randomized Treatment; Q4W Lampalizumab: Randomized Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complement Factor I (CFI) profile biomarker-positive result
• Women of child bearing potential and men should remain abstinent or use contraceptive methods

You may not qualify if:

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
• Previous subfoveal focal laser photocoagulation in study eye
• Laser photocoagulation in the study eye
• Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
• Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
• Previous cell-based intraocular treatment in study eye
• Intraocular surgery in study eye
• Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
• History of corneal transplant in study eye
• GA in either eye due to causes other than AMD
• Proliferative diabetic retinopathy in either eye
• Active or history of neovascular (wet) AMD in either eye
• History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
• Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
• Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (36)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206, United States

Location

University of Arizona; Banner University Medical, Department of Opthalmology

Tucson, Arizona, 85711, United States

Location

Northwest Arkansas Retina Associates

Springdale, Arkansas, 72764, United States

Location

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

San Diego Retina Associates

Oceanside, California, 92056, United States

Location

West Coast Retina Medical Group

San Francisco, California, 94109, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Colorado Retina Associates, PC

Golden, Colorado, 80401, United States

Location

Florida Eye Microsurgical Inst

Boynton Beach, Florida, 33426, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Care Specialists

Palm Beach Gardens, Florida, 33410, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Elman Retina Group

Baltimore, Maryland, 21237, United States

Location

Vitreoretinal Surgery

Edina, Minnesota, 55435, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87102, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Retina Assoc of Cleveland Inc

Cleveland, Ohio, 44122, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73099, United States

Location

Retina Cons of Charleston

Charleston, South Carolina, 29414, United States

Location

Carolina Retina Center PA

Columbia, South Carolina, 29223, United States

Location

Charles Retina Institution

Germantown, Tennessee, 38138, United States

Location

Southeastern Retina Associates

Knoxville, Tennessee, 37923, United States

Location

Tennessee Retina PC.

Nashville, Tennessee, 37203, United States

Location

W Texas Retina Consultants PA

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Specialists

DeSoto, Texas, 75115, United States

Location

Wagner Macula & Retina Center

Norfolk, Virginia, 23451, United States

Location

MeSH Terms

Conditions

Geographic Atrophy

Interventions

salicylhydroxamic acid; lampalizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

global.trial_information@roche.com

(+41) 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: March 30, 2015
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: September 25, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-09

Locations

US (36)